CHOCOLATE TOUCH®, THE NEXT-GENERATION DRUG-COATED ANGIOPLASTY BALLOON FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE, RECEIVES FDA APPROVAL

SINGAPORE, November 11, 2022 /PRNewswire/ — Genesis MedTech Group today announced that the Food and Drug Administration (FDA) has approved the Chocolate Touch® drug-coated balloon ATP catheter, developed by TriReme Medical LLC, for the treatment of patients with peripheral arterial disease in the superficial region the femoral artery and the popliteal artery.

Chocolate Touch® drug coated balloon (DCB) has been shown to have statically superior patency and non-inferior safety at 12 months compared to Lutonix® DCB based on a randomized head-to-head patient trial with symptomatic femoropopliteal disease[1].

  • The Chocolate Touch showed statistical superiority in its primary efficacy endpoint of actual DCB success over 12 months – a measure of the target vessel remaining patent without the need for a salvage stent. Primary patency was 78.8% for Chocolate Touch and 67.7% for Lutonix DCB at 12 months (psuperiority=0.0386); by Kaplan-Meier (KM) estimates it was 83.3% for Chocolate Touch and 73.0% for Lutonix DCB at 12 months[1]
  • The primary safety endpoint of freedom from major adverse events (MAEs) over 12 months was 88.9% for those treated with Chocolate Touch versus 84.6% for Lutonix DCB (Pnon-inferiority [1]
  • The Chocolate Touch results reported the lowest value of all-cause mortality from KM compared to mortality reported for FDA-approved DCBs in pivotal studies. Mortality rates for Chocolate Touch using 3-year KM estimates were 6.7% for Chocolate Touch and 11.1% for Lutonix DCB.

“I am very pleased to see that the Chocolate Touch, a next-generation drug-coated balloon, is now available to patients across the United States. This technology is an important tool in the therapeutic armamentarium for treating patients with peripheral arterial disease,” said Mehdi H. Shishehbor, DO, MPH, PhD, Harrington Heart & Vascular Institute University Hospitals, Cleveland, Ohiothe co-principal investigator of the Chocolate Touch trial.

The Chocolate Touch® drug-coated balloon is the world’s first and only balloon catheter that integrates the delivery of therapeutic agents with the next-generation angioplasty platform, for the treatment of peripheral arterial disease. Chocolate Touch® is designed to break open in small sections using pillow-like structures coated with a therapeutic agent. With the aim of providing patients with peripheral arterial disease with an alternative treatment to traditional drug-coated balloon angioplasty.

“This next-generation paclitaxel DCB is based on chocolate’s mechanism of pillow-and-groove formation, resulting in increased balloon surface area facilitating efficient drug delivery to the vessel wall and potentially reducing the need for permanent implants. The recently completed randomized controlled study demonstrated excellent primary outcomes, with statistical efficacy superior to the control drug-coated balloon. The Chocolate Touch is a class of drug-coated balloon in its own right,” said commented the co-principal research professor Thomas ZellerUniversitaets-Herzzentrum, Bad Krozingen, Germany.

warren wangPresident and CEO of Genesis MedTech Group, said, “The FDA approval of Chocolate Touch® provides American physicians and their patients with a next-generation drug-coated balloon with exceptional safety and efficacy to use. in the treatment of patients with PAD. This approval demonstrates our commitment to providing innovative solutions to improve the standard of care for millions of patients suffering from peripheral vascular disease.”

The company plans to launch this product in the United States through its subsidiary G Vascular.

About Chocolate Touch® Drug Coated Balloon (DCB)
The Chocolate Touch® (Paclitaxel-coated ATP balloon catheter) is indicated for the percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native femoral or popliteal arteries with reference vessel diameters of 4.0 mm to 6.0 mm.

About Genesis MedTech Group
Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally and in Asia, the company’s product portfolio is focused on multi-therapy medical device products for emerging markets with sales and distribution through its established sales network. Genesis MedTech Group covers the entire industry value chain from research and development, production, quality management, supply chain, marketing and sales.

For more information visit http://www.genesismedtech.com

About G Vascular Pte Ltd
G Vascular is a subsidiary of Genesis MedTech Group, specializing in the development of innovative products for peripheral vascular diseases. Its first technology, the Chocolate Touch®, is a next-generation drug-coated balloon and the world’s first balloon catheter that integrates the delivery of therapeutic agents with the next-generation angioplasty platform, for the treatment peripheral arterial disease.

About the CSA[2]
Affecting 200 million patients worldwide, peripheral arterial disease (PAD) is a slow and progressive circulatory disorder, caused by a narrowing, blockage or spasm in a blood vessel. The arteries of the legs and feet are the most affected. Complications of PAD may include amputation (loss of a limb), poor wound healing, reduced mobility due to pain or discomfort, severe pain in the affected extremity, or an accident cerebrovascular (3 times more likely in people with PAD).

References

  1. MH Shishehbor, T Zeller, M Werner, M Brodmann, H Parise, A Holden, M Lichtenberg, SA Parikh, VS Kashyap, C Pietras, D Tirziu, S Ardakani, U Beschorner, P Krishnan, KA Niazi, AU Wali, AJ Lansky . Randomized trial of Chocolate Touch versus Lutonix drug-coated balloon in femoropopliteal lesions (Chocolate Touch study). Traffic. 2022; 145: 1645–1654
  2. Creager MA, Loscalzo J. Chapter 275: Arterial diseases of the extremities. In: Jameson J, Fauci AS, Kasper DL, Hauser SL, Longo DL, Loscalzo J. eds. Harrison’s Principles of Internal Medicine. McGraw-Hill; Accessed August 28, 2020.

SOURCE Genesis MedTech